A Study of CG-806 in Patients With Relapsed or Refractory CLL/SLL or Non-Hodgkin's Lymphomas
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Blood Cancer, Lymphoma, Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/30/2019 |
| Start Date: | April 2019 |
| End Date: | December 2020 |
| Contact: | Nicole Harada |
| Email: | nharada@aptose.com |
| Phone: | 8589262730 |
A Phase Ia/b Trial to Evaluate the Safety and Tolerability of CG-806 in Patients With CLL/SLL or Non-Hodgkin's Lymphomas
This study is being done to evaluate the safety, tolerability and effectiveness of CG-806 for
the treatment of patients with the condition of chronic lymphocytic leukemia (CLL), small
lymphocytic lymphoma (SLL), or Non-Hodgkin's Lymphomas for which either the standard
treatment has failed, is no longer effective, or can no longer be administered safely or
poses a risk for your general well being.
the treatment of patients with the condition of chronic lymphocytic leukemia (CLL), small
lymphocytic lymphoma (SLL), or Non-Hodgkin's Lymphomas for which either the standard
treatment has failed, is no longer effective, or can no longer be administered safely or
poses a risk for your general well being.
This is a multicenter, open-label, Phase Ia/b dose escalation study of safety,
pharmacodynamics, and pharmacokinetics of CG-806 in ascending cohorts (3+3 design) to
determine the MTD or recommended dose in patients with relapsed or refractory CLL/SLL or
Non-Hodgkin's Lymphoma patients. This is to be followed by a cohort expansion phase at the
MTD or recommended dose.
pharmacodynamics, and pharmacokinetics of CG-806 in ascending cohorts (3+3 design) to
determine the MTD or recommended dose in patients with relapsed or refractory CLL/SLL or
Non-Hodgkin's Lymphoma patients. This is to be followed by a cohort expansion phase at the
MTD or recommended dose.
Inclusion Criteria:
- Age ≥ 18 years
- Life expectancy of at least 2 months
- ECOG Performance Status ≤ 2
- Patients must be able to swallow capsules
- Adequate hematologic parameters, unless cytopenias are disease caused
- Adequate renal, liver and cardiac function parameters
Exclusion Criteria:
- Patients with GVHD requiring systemic immunosuppressive therapy
- Uncontrolled leptomeningeal disease, auto-immune hemolytic anemia and uncontrolled and
clinical significant disease related metabolic disorder
- Clinically significant intravascular coagulation
- Treatment with other investigational drugs within 14 days prior to first study
treatment administration
We found this trial at
3
sites
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Monterey, California 93940
Principal Investigator: Laura Stampleman, MD
Phone: 831-375-4105
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San Diego, California 91351
Principal Investigator: Erin Reid, MD
Phone: 858-534-5201
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